我国药品安全规制的现实困境与完善路径

The Realistic Dilemma and the Perfecting Path of Drug Safety Regulation in China

药品是具有重要民生意义的特殊商品。药品安全规制既是完善国民健康政策的客观需要,也是深化医药卫生体制改革的内在要求。然而,我国药品安全规制还存在种种问题,在借鉴国外先进经验的基础上,再结合我国国情的前提下,提出了完善我国药品安全规制的措施。

In our country at present, medicine is a special commodity with important livelihood significance. When 19 th CPC National Congress of the Party emphasizes the implementation of the great strategy of healthy China, it is necessary to make it clear that the regulation of drug safety is not only the objective need of perfecting the national health policy, but also the inherent requirement of deepening the reform of the medical and health system. But in practice, China’s drug safety regulation is faced with three major practical difficulties: the supervision efficiency of the competent authorities is low;the pharmaceutical enterprises lack of self-control;the pharmaceutical industry lack of self-discipline. To this end, the mode of combination of foreign reference and local governance is the perfect way of drug safety regulation in China. On the one hand, we need to learn from abroad: by drawing lessons from the United States, France and France.On the other hand, it needs local governance: changing the concept of drug law enforcement, perfecting drug enforcement activities and promoting the socialization of drug service. Only by sticking to the key points, perfecting the system and guiding the expectation can we effectively guarantee the safety of drugs in China.